Tag: cell and gene therapy

Clinical Research: Phase 1 - Phase 4

Clinical Researcher: Advanced Therapies – Strategies for Success in Clinical Development

Advanced therapy medicinal product (ATMP) development is on the rise. According to the American Society of Gene + Cell Therapy, there were 1,745 gene therapies in development in May 2021, 70% of which were in preclinical studies, and more than 1,300 of these candidates were in development for oncology, the most active therapeutic area. Given...

Clinical Research: Phase 1 - Phase 4

Pharmaceutical Outsourcing: Optimizing Study Execution for Advanced Therapies

Advanced therapies – including gene-, cell-, and tissue-based products – offer groundbreaking new opportunities for the treatment of disease. As of the end of 2020, there were 1,085 active developers of these therapies and 152 ongoing Phase 3 trials worldwide. According to the Alliance for Regenerative Medicine, regulatory decisions are expected on a record eight...

Clinical Research: Phase 1 - Phase 4

The Medicine Maker: The Winding Road to the Frontline for Advanced Therapies

According to the Alliance for Regenerative Medicine, there were 1,085 active advanced therapy medicinal product (ATMP) developers and more than 150 phase III trials underway at the end of 2020. These numbers are not small, and they make it clear that ATMPs have much to offer in helping us overcome as-yet undefeated diseases.ATMPs are different...

Clinical Research: Phase 1 - Phase 4

ContractPharma: Gene Therapy Trials

Since the first gene therapy trial in 1990, the regulatory landscape has shifted from broad, loosely defined guidance with little variation between different cell and gene therapies to a more robust collection of guidelines and directives focused on testing and manufacturing considerations for these products in specific disease states and therapeutic settings. This article will...

Clinical Research: Phase 1 - Phase 4

PharmaTimes: Keeping Pace

In recent years, the gene therapy regulatory landscape has evolved from a broad, general guidance to a narrower focus on testing and manufacturing considerations in specific disease states. This article explores how factors such as environmental risk assessment and biosafety can impact gene therapy clinical study start-up as well as the continuing evolution of guidances...

Clinical Research: Phase 1 - Phase 4

Achieving the Promise of Gene Therapy: New Pathways to Overcome Patient Enrollment and Safety Challenges, Upcoming Webinar

TORONTO (PRWEB) SEPTEMBER 15, 2020 Though gene therapy has been around for decades, it continues to pose extraordinary challenges in the areas of R&D, clinical development, and operation of clinical trials. Sponsors and CROs face shifting operational and regulatory demands amid rapid advances in the science of precision medicine. This webinar will examine the evolving...